Postdoctoral Research Fellow involved in legal research for sustainable textile value chains. Collaborating with researchers on a funded project for law and circular economy.
About the role
- PK Sciences project team representative developing pharmacology strategies for transformative new medicines. Collaborates in clinical development, providing insights on drug candidates and dosing strategies.
Responsibilities
- Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate
- Proactively contributes to developing drug candidates across Research Development and Commercial continuum, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input
- Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions
- Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development
- Provide PK, dosage, and PK/PD components of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions
- Drive close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), through PK science sub-teams.
- Works in close collaboration with clinicians and clinical development colleagues to integrate PKS insights into study design, data interpretation, and project decision‑making
- Use of Artificial intelligence (AI) / Machine Learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, authoring regulatory documents, and the use of predictive models
Requirements
- Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
- A minimum of 0-2 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).
- 2+ years of experience preferably in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development to be considered for Principal Scientist II.
- Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation.
- Experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
- Exposure to working in a cross-functional, matrixed, project-team environment.
- Strong oral and written communication skills.
Benefits
- health, life and disability benefits
- 401(k) with company contribution and match
- generous time off package including vacation, personal days, holidays and other leaves
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